- The FDA accepts for review Puma Biotechnology's (NYSE:PBYI) New Drug Application (NDA) seeking approval of neratinib (PB272) for the extended adjuvant treatment of patients with early-stage HER2+ breast cancer who have been previously treated with adjuvant trastuzumab-based therapy (Roche's Herceptin).
- The data supporting the filing was generated in the Phase 3 ExteNET study which showed treatment with neratinib resulted in a 33% reduction in the risk of invasive disease recurrence or death versus placebo (hazard ratio: 0.67; p=0.009).
- The specific FDA action date (PDUFA) is not provided, but should be in July 2017.